Retrospective Review of Premarket Approval Application Devices; Striking the Balance Between Premarket and Postmarket Data Collection, 52445-52449 [2016-18672]
Download as PDF
Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
mstockstill on DSK3G9T082PROD with NOTICES
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–N–1092 for ‘‘Over-the-Counter
Monograph User Fees: Reopening of
Comment Period; Stakeholder Meeting.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
VerDate Sep<11>2014
22:23 Aug 05, 2016
Jkt 238001
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Amy Bertha, Office of Executive
Programs, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–1647, email:
OTCMonographUserFeeProgram
@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is reopening until October 6,
2016, the comment period for the
document that announced a public
meeting in the Federal Register of May
11, 2016 (81 FR 29275). In the
document, FDA invited public comment
as the Agency considers a user-fee
program for nonprescription (over-thecounter or OTC) monograph drugs. A
user-fee program would provide funding
to supplement congressional non-userfee appropriations, and would support
timely and efficient FDA review of the
efficacy and safety of ingredients
included in or proposed for inclusion in
a monograph. A public meeting on this
topic was held on June 10, 2016, and
interested persons were given until July
11, 2016, to submit comments. To
ensure that all interested persons have
sufficient opportunity to share their
views on a potential OTC monograph
user-fee program, FDA is reopening the
comment period until October 6, 2016.
FDA will hold a Webinar for
stakeholders on September 6, 2016. This
Webinar is intended to be a followup to
the June 10, 2016, public meeting and
provide stakeholders with a status
update on the process of FDA and
industry discussions that began in July
2016. Meeting minutes from these
discussions can be found at: https://
www.fda.gov/omuf. Additional
background information on OTC
monograph drugs (such as how OTC
drugs can be marketed, the differences
between marketing through approved
applications and marketing under the
monographs), factors FDA considers
important in developing a user-fee
program, and the questions FDA asked
the public to consider and provide
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
52445
input, can be found in the Federal
Register document from the June 10,
2106, public meeting (https://
www.federalregister.gov/articles/2016/
05/11/2016-11098/over-the-countermonograph-user-fees-public-meetingrequest-for-comments). The meeting
transcript, meeting recording, and
presentations from the June 10, 2016,
public meeting, which can serve as
further background information, can be
found at: https://www.fda.gov/Drugs/
NewsEvents/ucm499390.htm.
II. Stakeholder Meeting Participation
FDA is seeking participation at the
Webinar by stakeholders, including
scientific and academic experts, health
care professionals, representatives of
patient and consumer advocacy groups,
and representatives of the OTC
monograph industry. Participating in
the Webinar is free. The Webinar format
will include presentations by FDA staff
and an opportunity for stakeholders to
ask questions. If you wish to attend the
Webinar, FDA asks that you please
register through Eventbrite by Tuesday,
August 30, 2016 (https://
www.eventbrite.com/e/over-the-countermonograph-user-fees-stakeholdermeeting-tickets-26751882601). FDA will
email the registered attendees a URL to
join the Webinar at least 1 day before
the meeting.
Dated August 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–18717 Filed 8–5–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–1805]
Retrospective Review of Premarket
Approval Application Devices; Striking
the Balance Between Premarket and
Postmarket Data Collection
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
Administration (FDA) is announcing the
completion of the target of the goal
established to address the Center for
Devices and Radiological Health’s
(CDRH) 2014–2015 Strategic Priority
‘‘Strike the Right Balance Between
Premarket and Postmarket Data
Collection.’’ To achieve this Strategic
Priority, CDRH established a goal to
assure the appropriate balance between
premarket and postmarket data
SUMMARY:
E:\FR\FM\08AUN1.SGM
08AUN1
52446
Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices
collection to facilitate and expedite the
development and review of medical
devices, in particular high-risk devices
of public health importance. We
established a target date of December 31,
2015, by which to review 100 percent of
product codes subject to a premarket
approval application (PMA) that are
legally marketed and were approved
prior to 2010 to determine, for each
such product code, whether or not,
based on our current understanding of
the technology, to reduce premarket
data collection by relying more on
postmarket controls, and whether to
shift some premarket data collection to
the postmarket setting or to pursue
down-classification.
DATES: Submit either electronic or
written comments by October 7, 2016.
ADDRESSES: You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
mstockstill on DSK3G9T082PROD with NOTICES
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
VerDate Sep<11>2014
22:23 Aug 05, 2016
Jkt 238001
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2015–N–1805 for ‘‘Retrospective Review
of Premarket Approval Application
Devices; Striking the Balance Between
Premarket and Postmarket Data
Collection.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Nancy Braier, Center for Devices and
Radiological Health, Food and Drug
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5454, Silver Spring,
MD 20993–0002, 301–796–5676.
SUPPLEMENTARY INFORMATION:
I. Background
One of three Strategic Priorities for
2014–2015 in CDRH is to ‘‘Strike the
Right Balance Between Premarket and
Postmarket Data Collection’’ (Ref. 1).1
CDRH’s vision is for patients in the
United States to have first-in-the-world
access to high-quality, safe, and
effective medical devices of public
health importance. A key determinant of
early U.S. patient access to high-quality,
safe, and effective devices is the extent
of premarket data that device developers
provide to FDA. Once a device
developer decides to seek U.S.
marketing approval or clearance, the
extent of data that are collected
premarket has an impact upon the
length of time needed to complete a
premarket submission—the more data to
be collected premarket, the longer it
may take to acquire the data and make
the submission. Consequently, such
data collection issues affect when U.S.
patients have access to a medical
device. On the other hand, it is also
important that there are sufficient data
to demonstrate a reasonable assurance
of safety and effectiveness before a
device that is subject to a premarket
approval application (PMA) is approved
for marketing in the United States. For
this reason, it is important that CDRH
strike the right balance between
premarket and postmarket data
collection. If CDRH can shift, when
appropriate, some premarket data
collection to the postmarket setting,
CDRH could improve patient access to
high-quality, safe, and effective medical
devices of public health importance.
However, patient safety could be
undermined if, after determining that
certain data could appropriately be
shifted from the premarket to the
postmarket setting, CDRH shifted that
data collection to the postmarket setting
without adequate assurances that
necessary and timely postmarket data
collection will occur. For this reason,
CDRH strives to balance the premarket
data and postmarket collection, in
accordance with section 513(a)(3)(C) (21
U.S.C. 360c(a)(3)(C)) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act), which directs CDRH to
consider whether the extent of data that
otherwise would be required for
1 CDRH’s 2014–2015 Strategic Priorities include
‘‘Strengthen the Clinical Trial Enterprise’’ and
‘‘Provide Excellent Customer Service’’ in addition
to ‘‘Strike the Right Balance Between Premarket and
Postmarket Data Collection’’ (Ref. 1).
E:\FR\FM\08AUN1.SGM
08AUN1
mstockstill on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices
approval of a PMA with respect to
effectiveness can be reduced through
reliance on postmarket controls.
In order to achieve the proper balance
between premarket and postmarket data
collection, CDRH resolved in its
Strategic Priorities for 2014–2015 to take
several actions. CDRH committed to
developing and seeking public comment
on a framework for when it would be
appropriate to shift premarket data
collection to the postmarket setting.
Pursuant to this commitment, CDRH
and the Center for Biologics Evaluation
and Research (CBER) issued the
guidance, ‘‘Balancing Premarket and
Postmarket Data Collection for Devices
Subject to Premarket Approval,’’ on
April 13, 2015 (80 FR 19672), which
provided FDA’s policy of balancing
premarket and postmarket data
collection during the Agency’s review of
PMAs (Ref. 2). This guidance outlines
how FDA would consider the role of
postmarket information in determining
the appropriate type and amount of data
that should be collected in the
premarket setting to support premarket
approval, while still meeting the
statutory standard of a reasonable
assurance of safety and effectiveness.
Furthermore, under existing authorities,
CDRH and CBER issued a guidance
document on April 13, 2015 (80 FR
19669), entitled ‘‘Expedited Access for
Premarket Approval Medical Devices
Intended for Unmet Medical Need for
Life Threatening or Irreversibly
Debilitating Diseases or Conditions’’
(Ref. 3). This guidance describes FDA’s
voluntary expedited access PMA
program for certain medical devices to
facilitate patient access to these devices
by expediting the development,
assessment, and review of certain
devices that demonstrate the potential
to address unmet medical needs for life
threatening or irreversibly debilitating
diseases or conditions. To expedite
access for devices addressing unmet
needs, this pathway to market shifts
appropriate components of premarket
data collection to the postmarket setting,
while maintaining the statutory
standard of a reasonable assurance of
safety and effectiveness. In addition,
CDRH has developed a mechanism to
assure prospectively the appropriate
balance of premarket and postmarket
data collection for new devices subject
to a PMA. Specifically, when CDRH
issues a final decision for an original
PMA or panel-track supplement to a
PMA, CDRH conducts a prospective
assessment to determine if the device
type is a candidate for shifting some
premarket data collection to the
postmarket, reducing premarket data
VerDate Sep<11>2014
22:23 Aug 05, 2016
Jkt 238001
collection through reliance on
postmarket controls or reclassification.
Another action in pursuit of the goal
to strike the right balance between
premarket and postmarket data
collection was to commit to conducting
a retrospective review of all PMA
product codes (procodes) with active
PMAs approved prior to 2010 to
determine whether data typically
collected premarket could be shifted to
the postmarket setting, and whether
premarket data collection could be
reduced through reliance on postmarket
controls or devices could be reclassified
(down-classified) in light of our current
understanding of the technology (Ref.
1). In general, some premarket data
collections for class III devices that are
currently marketed may be reduced
through reliance on postmarket controls
or shifted to the postmarket setting if
warranted, based on CDRH’s review
experience as well as the postmarket
performance and the current body of
evidence regarding the benefit-risk
profile of these devices. CDRH currently
receives PMA submissions on the
majority of these class III devices, and
a change in premarket data collection is
expected to expedite the approval of
future PMA submissions. CDRH has
periodically taken such actions
consistent with the medical device
statutory framework but has typically
done so on an ad hoc basis. On the other
hand, when FDA determines that it is
necessary to provide reasonable
assurance that a device is safe and
effective, CDRH may require more data
based on our current understanding of
that type of technology or based on an
issue raised by the data submitted by a
sponsor for their device. CDRH will also
up-classify a device, if warranted, based
on the current state of the science. For
example, on January 5, 2016, CDRH
issued a final order up-classifying
surgical mesh when intended for use for
pelvic organ prolapse (81 FR 354), and
on June 2, 2014, CDRH issued a final
order up-classifying sunlamps and
sunlamp products (tanning beds/booths)
(79 FR 31205). However, upclassification is not warranted for the
devices subject to this retrospective
review, because they are already in the
highest risk classification.
During this retrospective review,
devices were analyzed according to
procodes. CDRH targeted the date of
December 31, 2014, by which to review
50 percent of the procodes for devices
that are subject to a PMA and are legally
marketed to determine whether or not to
change premarket data collection by
shifting the data collection to the
postmarket setting, reducing premarket
data collection through reliance on
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
52447
postmarket controls, or pursuing
reclassification (Ref. 1). This target
extended to have 75 percent completed
by June 30, 2015, and 100 percent
completed by December 31, 2015.
On April 29, 2015, CDRH announced
its progress on this priority and solicited
comments on the procodes that were
identified as candidates for
reclassification, a reduction in
premarket data collection through
reliance on postmarket controls, or a
shift in premarket data collection to
postmarket for those procodes reviewed
through December 31, 2014 (80 FR
23798). FDA received 11 sets of
comments, which generally supported
FDA’s retrospective review effort and
provided input on specific procodes
that were identified as candidates for
reclassification or were determined to
remain class III with no changes in data
collection. FDA will consider these
comments when making final
determinations on the reclassification of
these procodes.
During 2015, FDA reviewed the
remaining procodes that were identified
for the retrospective review. While
completing the retrospective review,
FDA found that the LMX procode was
included in the retrospective review in
error, because the jaundice meter device
type is covered by a different procode,
not within the scope of the retrospective
review. The jaundice meter device type
is classified under 21 CFR 862.1113 and
assigned the procode MQM, and
accordingly, this device type requires a
510(k) premarket notification.
Therefore, the procode LMX has been
excluded from the analysis.
The purpose of this Federal Register
notice is to solicit comments on the
remaining procodes that have been
identified as candidates for
reclassification, a reduction in
premarket data collection through
reliance on postmarket controls, or a
shift in premarket data collection to
postmarket for those procodes reviewed
through December 31, 2015. Efforts to
reclassify and to communicate changes
to data collections with stakeholders
will be prioritized based on both the
public health impact and Center
resources.
II. Achievement of Goal Targets
Retrospective analysis of the class III
medical device procodes was intended
to determine if current classifications
and data collections remain appropriate
for determining a reasonable assurance
of safety and effectiveness. As our
understanding of the technology
associated with individual medical
devices has increased and we have a
better understanding of the risks
E:\FR\FM\08AUN1.SGM
08AUN1
mstockstill on DSK3G9T082PROD with NOTICES
52448
Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices
associated with the technology of each
device, our understanding of the type
and amount of data that are needed to
demonstrate a reasonable assurance of
safety and effectiveness also evolves.
We use this evolution in our
understanding to require the least
burdensome amount of data necessary
to evaluate device effectiveness,
following the least burdensome
provisions of the FD&C Act (section
513(a)(3)(D)(ii)). Under section 513 of
the FD&C Act, a device is a class III
device and requires premarket approval
if general controls and special controls
are insufficient to provide reasonable
assurance of the safety and effectiveness
of the device, and if the device is to be
used for supporting or sustaining
human life or of substantial importance
in preventing impairment of human
health or if the device presents a
potential unreasonable risk of illness or
injury. In order to reclassify a class III
device into class II, the device must
meet the statutory criteria for class II: A
device that cannot be classified as a
class I device, because general controls
are insufficient to provide reasonable
assurance of the safety and effectiveness
of the device, and for which there is
sufficient information to establish
special controls to provide such
assurance. As new information becomes
available over time, the accumulated
information available for a device may
be sufficient to establish special controls
to provide a reasonable assurance of
safety and effectiveness; therefore, the
classification of the device may be
changed either up or down.
In February 2014, CDRH began its
retrospective review with procodes
associated with active PMAs approved
prior to 2010. PMA procodes created
since 2010 were not included in this
retrospective review because these
recently created procodes do not yet
have sufficient new information for a
change in FDA’s current understanding
of the device’s postmarket performance
profile. As of December 31, 2015, CDRH
reviewed all procodes included in this
retrospective review, meeting its 100
percent review target.
The results of this analysis include
recommendations for procodes that are
candidates for reclassification, a
reduction in premarket data collection
through reliance on postmarket controls,
or a shift in premarket data collection to
postmarket collection. These results are
published online, along with the results
of the first cohort of procodes at https://
www.fda.gov/AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/
CDRH/CDRHVisionandMission/
default.htm (Ref. 4). The results of this
second cohort of procodes reviewed for
VerDate Sep<11>2014
22:23 Aug 05, 2016
Jkt 238001
this analysis are additive to those
previously reported. CDRH is
continuing to consider the comments
received on the first cohort of procodes
reported in April 2015, and efforts to
reclassify and to communicate changes
to data collections with stakeholders are
being prioritized based on both the
public health impact and Center
resources. The following paragraph
describes the organization of the results
into tables, which are available for
public review online (Ref. 4).
As discussed in further detail below,
for the purposes of this retrospective
review, we evaluated each procode on a
balance of factors to determine the
current benefit-risk profile and if our
review indicates special controls could
be established to provide a reasonable
assurance of safety and effectiveness. If
so, the corresponding procode was
listed in the category ‘‘Candidates for
Reclassification to Class II’’ (table 1). If
it was determined that special controls
would not be sufficient to provide
reasonable assurance of the safety and
effectiveness of the device, then the
procode was evaluated to determine if
some premarket data collection for PMA
submission could be shifted to
postmarket collection, or if premarket
data collection could be reduced
through reliance on postmarket controls.
If it was determined that a change of
data collection could continue to
provide reasonable assurance of the
safety and effectiveness of the device,
then the procode was listed in the
category ‘‘Candidates for reduction of
data collection through reliance on
postmarket controls or shift of data
collection from premarket to
postmarket’’ (table 2). This category
includes procodes for which premarket
data collection could be shifted to
postmarket data collection, premarket
data collection could be decreased
through reliance on postmarket controls,
or postmarket data could no longer be
needed. Finally, table 3 includes
procodes for which a reduction in data
collection through reliance on
postmarket controls or shift in data
collection from premarket to postmarket
and/or reclassification occurred in 2015
during FDA’s retrospective review of
PMAs.
In this retrospective review,
postmarket performance data,
technology and performance
considerations, and other relevant
considerations were evaluated for each
procode. These factors were used to
evaluate the current benefit-risk profile
to determine if the devices are good
candidates for a reduction in premarket
data collection through reliance on
postmarket controls, a shift of premarket
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
data collection to postmarket, or
reclassification. Postmarket performance
data (including recent PMA Annual
Reports, literature reviews, total product
lifecycle reports, medical device
reporting analysis, market penetration,
and recall analysis) were investigated
for any performance concerns or
problems that outpace any increases in
device use or acceptance. In evaluating
the technology and performance
considerations for the procodes,
performance concerns or problems that
were uncovered in the review of
postmarket data were considered
unfavorable factors for a change in data
collection or reclassification. Favorable
factors to indicate that a device is a good
candidate for a change in data collection
or reclassification included: Whether
risks are now well understood and are
determined to be moderate to low;
technology uncertainties have been
alleviated; performance standards or
non-clinical tests have been developed
that could be surrogates for some
clinical testing; the need for a controlled
study could be eliminated due to
defined objective performance criteria;
the device has been shown to have good
short-term performance; or concerns are
limited to long-term performance or rare
adverse events.
Finally, several relevant
considerations were evaluated for each
procode. Unfavorable factors for devices
to be considered candidates for a change
in data collection or reclassification
included: Whether there have been
significant changes implemented to
address safety or effectiveness since the
devices have been on the market;
whether the review of annual reports
and manufacturing changes has been
important to maintain safety of the
devices; whether there were a limited
number of approvals or limited clinical
use of the devices, due to inadequate
data needed to conduct this scientific
assessment.
After completion of this retrospective
review, FDA will prioritize the procodes
identified as candidates for
reclassification (table 1, Ref. 4)
according to public health impact and
Center resources, in order to determine
the top priority procodes for which
reclassification would have the greatest
impact. The procodes identified as top
priority candidates for reclassification
will proceed through the reclassification
procedures according to 21 CFR part
860. FDA will also prioritize the
procodes identified as candidates for a
change in data collection (table 2, Ref.
4) according to public health impact and
Center resources, in order to determine
which reductions of or shifts to data
collection would have the greatest
E:\FR\FM\08AUN1.SGM
08AUN1
Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices
impact. FDA encourages firms to submit
a presubmission to get feedback on their
data collection plan or contact the
appropriate review branch for
additional information if they are in the
process of developing a device in one of
these categories.
III. Paperwork Reduction Act of 1995
This document refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 814 have been approved
under OMB control number 0910–0231.
IV. References
mstockstill on DSK3G9T082PROD with NOTICES
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and are available for viewing by
interested persons between 9 a.m. and 4
p.m., Monday through Friday; they are
also available electronically at https://
www.regulations.gov. FDA has verified
the Web site addresses, as of the date
this document publishes in the Federal
Register, but Web sites are subject to
change over time.
1. FDA, ‘‘CDRH 2014–2015 Strategic
Priorities,’’ 2014, https://www.fda.gov/
downloads/AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/
CDRH/CDRHVisionandMission/
UCM384576.pdf.
2. ‘‘Guidance for Industry and FDA Staff:
Balancing Premarket and Postmarket
Data Collection for Devices Subject to
Premarket Approval,’’ April 2015, https://
www.fda.gov/ucm/groups/fdagov-public/
@fdagov-meddev-gen/documents/
document/ucm393994.pdf.
3. ‘‘Guidance for Industry and FDA Staff:
Expedited Access for Premarket
Approval and De Novo Medical Devices
Intended for Unmet Medical Need for
Life Threatening or Irreversibly
Debilitating Diseases or Conditions,’’
April 2015, https://www.fda.gov/ucm/
groups/fdagov-public/@fdagov-meddevgen/documents/document/
ucm393978.pdf.
4. ‘‘Second and final cohort of Results of the
2014–2015 Strategic Priority: Strike the
Right Balance between Premarket and
Postmarket Data Collection, ’’ available
at https://www.fda.gov/AboutFDA/
CentersOffices/
OfficeofMedicalProductsandTobacco/
CDRH/CDRHVisionandMission/
default.htm.
Dated: August 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–18672 Filed 8–5–16; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
22:23 Aug 05, 2016
Jkt 238001
52449
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Food and Drug Administration
Written/Paper Submissions
[Docket No. FDA–2016–D–2319]
Ulcerative Colitis: Clinical Trial
Endpoints; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Ulcerative Colitis: Clinical Trial
Endpoints.’’ The purpose of this
guidance is to assist sponsors in the
clinical development of drugs for the
treatment of ulcerative colitis (UC) in
adult and pediatric patients.
Specifically, this guidance addresses
FDA’s current thinking regarding
efficacy endpoints for UC clinical trials.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by October 7,
2016.
SUMMARY:
ADDRESSES:
You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–D–2319 for ‘‘Ulcerative Colitis:
Clinical Trial Endpoints; Draft Guidance
for Industry; Availability.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
E:\FR\FM\08AUN1.SGM
08AUN1
Agencies
[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Notices]
[Pages 52445-52449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18672]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-1805]
Retrospective Review of Premarket Approval Application Devices;
Striking the Balance Between Premarket and Postmarket Data Collection
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
completion of the target of the goal established to address the Center
for Devices and Radiological Health's (CDRH) 2014-2015 Strategic
Priority ``Strike the Right Balance Between Premarket and Postmarket
Data Collection.'' To achieve this Strategic Priority, CDRH established
a goal to assure the appropriate balance between premarket and
postmarket data
[[Page 52446]]
collection to facilitate and expedite the development and review of
medical devices, in particular high-risk devices of public health
importance. We established a target date of December 31, 2015, by which
to review 100 percent of product codes subject to a premarket approval
application (PMA) that are legally marketed and were approved prior to
2010 to determine, for each such product code, whether or not, based on
our current understanding of the technology, to reduce premarket data
collection by relying more on postmarket controls, and whether to shift
some premarket data collection to the postmarket setting or to pursue
down-classification.
DATES: Submit either electronic or written comments by October 7, 2016.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2015-N-1805 for ``Retrospective Review of Premarket Approval
Application Devices; Striking the Balance Between Premarket and
Postmarket Data Collection.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Nancy Braier, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5454, Silver Spring, MD 20993-0002, 301-796-5676.
SUPPLEMENTARY INFORMATION:
I. Background
One of three Strategic Priorities for 2014-2015 in CDRH is to
``Strike the Right Balance Between Premarket and Postmarket Data
Collection'' (Ref. 1).\1\ CDRH's vision is for patients in the United
States to have first-in-the-world access to high-quality, safe, and
effective medical devices of public health importance. A key
determinant of early U.S. patient access to high-quality, safe, and
effective devices is the extent of premarket data that device
developers provide to FDA. Once a device developer decides to seek U.S.
marketing approval or clearance, the extent of data that are collected
premarket has an impact upon the length of time needed to complete a
premarket submission--the more data to be collected premarket, the
longer it may take to acquire the data and make the submission.
Consequently, such data collection issues affect when U.S. patients
have access to a medical device. On the other hand, it is also
important that there are sufficient data to demonstrate a reasonable
assurance of safety and effectiveness before a device that is subject
to a premarket approval application (PMA) is approved for marketing in
the United States. For this reason, it is important that CDRH strike
the right balance between premarket and postmarket data collection. If
CDRH can shift, when appropriate, some premarket data collection to the
postmarket setting, CDRH could improve patient access to high-quality,
safe, and effective medical devices of public health importance.
However, patient safety could be undermined if, after determining that
certain data could appropriately be shifted from the premarket to the
postmarket setting, CDRH shifted that data collection to the postmarket
setting without adequate assurances that necessary and timely
postmarket data collection will occur. For this reason, CDRH strives to
balance the premarket data and postmarket collection, in accordance
with section 513(a)(3)(C) (21 U.S.C. 360c(a)(3)(C)) of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act), which directs CDRH to
consider whether the extent of data that otherwise would be required
for
[[Page 52447]]
approval of a PMA with respect to effectiveness can be reduced through
reliance on postmarket controls.
---------------------------------------------------------------------------
\1\ CDRH's 2014-2015 Strategic Priorities include ``Strengthen
the Clinical Trial Enterprise'' and ``Provide Excellent Customer
Service'' in addition to ``Strike the Right Balance Between
Premarket and Postmarket Data Collection'' (Ref. 1).
---------------------------------------------------------------------------
In order to achieve the proper balance between premarket and
postmarket data collection, CDRH resolved in its Strategic Priorities
for 2014-2015 to take several actions. CDRH committed to developing and
seeking public comment on a framework for when it would be appropriate
to shift premarket data collection to the postmarket setting. Pursuant
to this commitment, CDRH and the Center for Biologics Evaluation and
Research (CBER) issued the guidance, ``Balancing Premarket and
Postmarket Data Collection for Devices Subject to Premarket Approval,''
on April 13, 2015 (80 FR 19672), which provided FDA's policy of
balancing premarket and postmarket data collection during the Agency's
review of PMAs (Ref. 2). This guidance outlines how FDA would consider
the role of postmarket information in determining the appropriate type
and amount of data that should be collected in the premarket setting to
support premarket approval, while still meeting the statutory standard
of a reasonable assurance of safety and effectiveness. Furthermore,
under existing authorities, CDRH and CBER issued a guidance document on
April 13, 2015 (80 FR 19669), entitled ``Expedited Access for Premarket
Approval Medical Devices Intended for Unmet Medical Need for Life
Threatening or Irreversibly Debilitating Diseases or Conditions'' (Ref.
3). This guidance describes FDA's voluntary expedited access PMA
program for certain medical devices to facilitate patient access to
these devices by expediting the development, assessment, and review of
certain devices that demonstrate the potential to address unmet medical
needs for life threatening or irreversibly debilitating diseases or
conditions. To expedite access for devices addressing unmet needs, this
pathway to market shifts appropriate components of premarket data
collection to the postmarket setting, while maintaining the statutory
standard of a reasonable assurance of safety and effectiveness. In
addition, CDRH has developed a mechanism to assure prospectively the
appropriate balance of premarket and postmarket data collection for new
devices subject to a PMA. Specifically, when CDRH issues a final
decision for an original PMA or panel-track supplement to a PMA, CDRH
conducts a prospective assessment to determine if the device type is a
candidate for shifting some premarket data collection to the
postmarket, reducing premarket data collection through reliance on
postmarket controls or reclassification.
Another action in pursuit of the goal to strike the right balance
between premarket and postmarket data collection was to commit to
conducting a retrospective review of all PMA product codes (procodes)
with active PMAs approved prior to 2010 to determine whether data
typically collected premarket could be shifted to the postmarket
setting, and whether premarket data collection could be reduced through
reliance on postmarket controls or devices could be reclassified (down-
classified) in light of our current understanding of the technology
(Ref. 1). In general, some premarket data collections for class III
devices that are currently marketed may be reduced through reliance on
postmarket controls or shifted to the postmarket setting if warranted,
based on CDRH's review experience as well as the postmarket performance
and the current body of evidence regarding the benefit-risk profile of
these devices. CDRH currently receives PMA submissions on the majority
of these class III devices, and a change in premarket data collection
is expected to expedite the approval of future PMA submissions. CDRH
has periodically taken such actions consistent with the medical device
statutory framework but has typically done so on an ad hoc basis. On
the other hand, when FDA determines that it is necessary to provide
reasonable assurance that a device is safe and effective, CDRH may
require more data based on our current understanding of that type of
technology or based on an issue raised by the data submitted by a
sponsor for their device. CDRH will also up-classify a device, if
warranted, based on the current state of the science. For example, on
January 5, 2016, CDRH issued a final order up-classifying surgical mesh
when intended for use for pelvic organ prolapse (81 FR 354), and on
June 2, 2014, CDRH issued a final order up-classifying sunlamps and
sunlamp products (tanning beds/booths) (79 FR 31205). However, up-
classification is not warranted for the devices subject to this
retrospective review, because they are already in the highest risk
classification.
During this retrospective review, devices were analyzed according
to procodes. CDRH targeted the date of December 31, 2014, by which to
review 50 percent of the procodes for devices that are subject to a PMA
and are legally marketed to determine whether or not to change
premarket data collection by shifting the data collection to the
postmarket setting, reducing premarket data collection through reliance
on postmarket controls, or pursuing reclassification (Ref. 1). This
target extended to have 75 percent completed by June 30, 2015, and 100
percent completed by December 31, 2015.
On April 29, 2015, CDRH announced its progress on this priority and
solicited comments on the procodes that were identified as candidates
for reclassification, a reduction in premarket data collection through
reliance on postmarket controls, or a shift in premarket data
collection to postmarket for those procodes reviewed through December
31, 2014 (80 FR 23798). FDA received 11 sets of comments, which
generally supported FDA's retrospective review effort and provided
input on specific procodes that were identified as candidates for
reclassification or were determined to remain class III with no changes
in data collection. FDA will consider these comments when making final
determinations on the reclassification of these procodes.
During 2015, FDA reviewed the remaining procodes that were
identified for the retrospective review. While completing the
retrospective review, FDA found that the LMX procode was included in
the retrospective review in error, because the jaundice meter device
type is covered by a different procode, not within the scope of the
retrospective review. The jaundice meter device type is classified
under 21 CFR 862.1113 and assigned the procode MQM, and accordingly,
this device type requires a 510(k) premarket notification. Therefore,
the procode LMX has been excluded from the analysis.
The purpose of this Federal Register notice is to solicit comments
on the remaining procodes that have been identified as candidates for
reclassification, a reduction in premarket data collection through
reliance on postmarket controls, or a shift in premarket data
collection to postmarket for those procodes reviewed through December
31, 2015. Efforts to reclassify and to communicate changes to data
collections with stakeholders will be prioritized based on both the
public health impact and Center resources.
II. Achievement of Goal Targets
Retrospective analysis of the class III medical device procodes was
intended to determine if current classifications and data collections
remain appropriate for determining a reasonable assurance of safety and
effectiveness. As our understanding of the technology associated with
individual medical devices has increased and we have a better
understanding of the risks
[[Page 52448]]
associated with the technology of each device, our understanding of the
type and amount of data that are needed to demonstrate a reasonable
assurance of safety and effectiveness also evolves. We use this
evolution in our understanding to require the least burdensome amount
of data necessary to evaluate device effectiveness, following the least
burdensome provisions of the FD&C Act (section 513(a)(3)(D)(ii)). Under
section 513 of the FD&C Act, a device is a class III device and
requires premarket approval if general controls and special controls
are insufficient to provide reasonable assurance of the safety and
effectiveness of the device, and if the device is to be used for
supporting or sustaining human life or of substantial importance in
preventing impairment of human health or if the device presents a
potential unreasonable risk of illness or injury. In order to
reclassify a class III device into class II, the device must meet the
statutory criteria for class II: A device that cannot be classified as
a class I device, because general controls are insufficient to provide
reasonable assurance of the safety and effectiveness of the device, and
for which there is sufficient information to establish special controls
to provide such assurance. As new information becomes available over
time, the accumulated information available for a device may be
sufficient to establish special controls to provide a reasonable
assurance of safety and effectiveness; therefore, the classification of
the device may be changed either up or down.
In February 2014, CDRH began its retrospective review with procodes
associated with active PMAs approved prior to 2010. PMA procodes
created since 2010 were not included in this retrospective review
because these recently created procodes do not yet have sufficient new
information for a change in FDA's current understanding of the device's
postmarket performance profile. As of December 31, 2015, CDRH reviewed
all procodes included in this retrospective review, meeting its 100
percent review target.
The results of this analysis include recommendations for procodes
that are candidates for reclassification, a reduction in premarket data
collection through reliance on postmarket controls, or a shift in
premarket data collection to postmarket collection. These results are
published online, along with the results of the first cohort of
procodes at https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/default.htm
(Ref. 4). The results of this second cohort of procodes reviewed for
this analysis are additive to those previously reported. CDRH is
continuing to consider the comments received on the first cohort of
procodes reported in April 2015, and efforts to reclassify and to
communicate changes to data collections with stakeholders are being
prioritized based on both the public health impact and Center
resources. The following paragraph describes the organization of the
results into tables, which are available for public review online (Ref.
4).
As discussed in further detail below, for the purposes of this
retrospective review, we evaluated each procode on a balance of factors
to determine the current benefit-risk profile and if our review
indicates special controls could be established to provide a reasonable
assurance of safety and effectiveness. If so, the corresponding procode
was listed in the category ``Candidates for Reclassification to Class
II'' (table 1). If it was determined that special controls would not be
sufficient to provide reasonable assurance of the safety and
effectiveness of the device, then the procode was evaluated to
determine if some premarket data collection for PMA submission could be
shifted to postmarket collection, or if premarket data collection could
be reduced through reliance on postmarket controls. If it was
determined that a change of data collection could continue to provide
reasonable assurance of the safety and effectiveness of the device,
then the procode was listed in the category ``Candidates for reduction
of data collection through reliance on postmarket controls or shift of
data collection from premarket to postmarket'' (table 2). This category
includes procodes for which premarket data collection could be shifted
to postmarket data collection, premarket data collection could be
decreased through reliance on postmarket controls, or postmarket data
could no longer be needed. Finally, table 3 includes procodes for which
a reduction in data collection through reliance on postmarket controls
or shift in data collection from premarket to postmarket and/or
reclassification occurred in 2015 during FDA's retrospective review of
PMAs.
In this retrospective review, postmarket performance data,
technology and performance considerations, and other relevant
considerations were evaluated for each procode. These factors were used
to evaluate the current benefit-risk profile to determine if the
devices are good candidates for a reduction in premarket data
collection through reliance on postmarket controls, a shift of
premarket data collection to postmarket, or reclassification.
Postmarket performance data (including recent PMA Annual Reports,
literature reviews, total product lifecycle reports, medical device
reporting analysis, market penetration, and recall analysis) were
investigated for any performance concerns or problems that outpace any
increases in device use or acceptance. In evaluating the technology and
performance considerations for the procodes, performance concerns or
problems that were uncovered in the review of postmarket data were
considered unfavorable factors for a change in data collection or
reclassification. Favorable factors to indicate that a device is a good
candidate for a change in data collection or reclassification included:
Whether risks are now well understood and are determined to be moderate
to low; technology uncertainties have been alleviated; performance
standards or non-clinical tests have been developed that could be
surrogates for some clinical testing; the need for a controlled study
could be eliminated due to defined objective performance criteria; the
device has been shown to have good short-term performance; or concerns
are limited to long-term performance or rare adverse events.
Finally, several relevant considerations were evaluated for each
procode. Unfavorable factors for devices to be considered candidates
for a change in data collection or reclassification included: Whether
there have been significant changes implemented to address safety or
effectiveness since the devices have been on the market; whether the
review of annual reports and manufacturing changes has been important
to maintain safety of the devices; whether there were a limited number
of approvals or limited clinical use of the devices, due to inadequate
data needed to conduct this scientific assessment.
After completion of this retrospective review, FDA will prioritize
the procodes identified as candidates for reclassification (table 1,
Ref. 4) according to public health impact and Center resources, in
order to determine the top priority procodes for which reclassification
would have the greatest impact. The procodes identified as top priority
candidates for reclassification will proceed through the
reclassification procedures according to 21 CFR part 860. FDA will also
prioritize the procodes identified as candidates for a change in data
collection (table 2, Ref. 4) according to public health impact and
Center resources, in order to determine which reductions of or shifts
to data collection would have the greatest
[[Page 52449]]
impact. FDA encourages firms to submit a presubmission to get feedback
on their data collection plan or contact the appropriate review branch
for additional information if they are in the process of developing a
device in one of these categories.
III. Paperwork Reduction Act of 1995
This document refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 814 have been approved under
OMB control number 0910-0231.
IV. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they are also available electronically at https://www.regulations.gov. FDA has verified the Web site addresses, as of the
date this document publishes in the Federal Register, but Web sites are
subject to change over time.
1. FDA, ``CDRH 2014-2015 Strategic Priorities,'' 2014, https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/UCM384576.pdf.
2. ``Guidance for Industry and FDA Staff: Balancing Premarket and
Postmarket Data Collection for Devices Subject to Premarket
Approval,'' April 2015, https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm393994.pdf.
3. ``Guidance for Industry and FDA Staff: Expedited Access for
Premarket Approval and De Novo Medical Devices Intended for Unmet
Medical Need for Life Threatening or Irreversibly Debilitating
Diseases or Conditions,'' April 2015, https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm393978.pdf.
4. ``Second and final cohort of Results of the 2014-2015 Strategic
Priority: Strike the Right Balance between Premarket and Postmarket
Data Collection, '' available at https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/default.htm.
Dated: August 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18672 Filed 8-5-16; 8:45 am]
BILLING CODE 4164-01-P